DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claim Objections
The objection to claim 15 is withdrawn in view of the amendment thereto.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-11, 13 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 20110282587 to Jones.
Regarding Claim 1, Jones discloses a composition (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards with data received from an analytical system such as a mass spectrometer; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]), comprising: an alkaloid (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including caffeine (an alkaloid); ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]), and a diaryl ketone (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including Benzophenone (a diaryl ketone); ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 2, Jones discloses one or more solvents (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including water and methanol; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 3, Jones discloses the one or more solvents is a solvent pair including methanol and water (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including water and methanol; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 4, Jones discloses the one or more solvents are non-toxic (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including water; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 5, Jones discloses the diaryl ketone is a benzophenone (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including Benzophenone (a diaryl ketone); ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 6, Jones discloses one or more phthalates (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including Diethyl phthalate, Dimethyl phthalate, Dipentyl phthalate, Dibutyl phthalate, Dioctyl phthalate, etc.; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 7, Jones discloses the one or more phthalates is a di-alkyl phthalate (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including Diethyl phthalate, Dimethyl phthalate, Dipentyl phthalate, Dibutyl phthalate, Dioctyl phthalate, etc.; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 8, Jones discloses the one or more phthalates is hydrophobic (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including Diethyl phthalate, Dimethyl phthalate, Dipentyl phthalate, Dibutyl phthalate, Dioctyl phthalate, etc.; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]).
Regarding Claim 9, Jones discloses the composition is stable at room temperature (Figs. 1-2 and 5-6, NIST external standard sample having one or more added stable isotopic standards; ¶¶ [0017]-[0020], [0051], [0064]-[0071], [0086]-[0087]).
Regarding Claim 10, Jones discloses the composition is homogeneous (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards used in HPLC, i.e., a homogeneous liquid phase; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087], [0107]-[0115]).
Regarding Claim 11, Jones discloses the alkaloid comprises caffeine, uracil, and acetone (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including caffeine, uracil, and acetone; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087], [0098]).
Regarding Claim 13, Jones discloses the composition is stable for at least one year (Figs. 1-2 and 5-6, NIST external standard sample having one or more added stable isotopic standards; ¶¶ [0017]-[0020], [0051], [0064]-[0071], [0086]-[0087]).
Regarding Claim 16, Jones discloses a method of using a standard composition (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards with data received from an analytical system such as a mass spectrometer; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]), comprising: injecting the standard composition into a chromatograph system (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards injected in LC-FTMS or HPLC system; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087], [0110]-[0117]), wherein the standard composition comprises an alkaloid, and a diaryl ketone (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including caffeine (an alkaloid) and Benzophenone (a diaryl ketone); ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]); and detecting the elution rates for the alkaloid, and the diaryl ketone (Figs. 1-2 and 5-6, detecting elution time in LC-FTMS system; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087], [0110]-[0117]).
Claim(s) 9-10,13-15 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of US 20140033793 to Thorson.
Regarding Claim 9, Jones implicitly discloses the composition is stable at room temperature (Figs. 1-2 and 5-6, NIST external standard sample having one or more added stable isotopic standards; ¶¶ [0017]-[0020], [0051], [0064]-[0071], [0086]-[0087]). Thorson explicitly discloses the composition is stable at room temperature (¶¶ [0004], [0211], [0249]; e.g., "when stored properly, the composition of the reference solutions will not change appreciably over time", through expiration date and/or sufficiently homogeneous and stable with reference to specified properties which have been established to be fit for its intended use in measurement or in examination of nominal properties). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing the composition is stable for at least one year as in Thorson in order to provide greater efficiency.
Regarding Claim 10, Jones implicitly discloses the composition is homogeneous (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards used in HPLC, i.e., a homogeneous liquid phase; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087], [0107]-[0115]). Thorson explicitly discloses the composition is homogeneous (¶¶ [0004], [0211], [0249]; e.g., "when stored properly, the composition of the reference solutions will not change appreciably over time", through expiration date and/or sufficiently homogeneous and stable with reference to specified properties which have been established to be fit for its intended use in measurement or in examination of nominal properties). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing the composition is stable for at least one year as in Thorson in order to provide greater efficiency.
Regarding Claim 13, Jones implicitly discloses the composition is stable for at least one year (Figs. 1-2 and 5-6, NIST external standard sample having one or more added stable isotopic standards; ¶¶ [0017]-[0020], [0051], [0064]-[0071], [0086]-[0087]). Thorson explicitly discloses the composition is stable for at least one year (¶¶ [0004], [0211], [0249]; e.g., "when stored properly, the composition of the reference solutions will not change appreciably over time", through expiration date and/or sufficiently homogeneous and stable with reference to specified properties which have been established to be fit for its intended use in measurement or in examination of nominal properties). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing the composition is stable for at least one year as in Thorson in order to provide greater efficiency.
Regarding Claim 14, Jones discloses a composition comprising an alkaloid, and a diaryl ketone. (See claim 1) but is silent regarding a kit, comprising: one or more containers, wherein each of the one or more containers includes the composition. Thorson discloses a kit, comprising: one or more containers, wherein each of the one or more containers includes the composition (¶¶ [0026], [0037], [0211]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing a kit, comprising: one or more containers, wherein each of the one or more containers includes the composition as in Thorson in order to provide greater efficiency in evaluating the condition of the chromatography system.
Regarding Claim 15, Thorson discloses the one or more containers is an ampule (¶ [0211]).
Regarding Claim 17, Jones discloses the method of claim 16, but is silent regarding the step of injecting includes removing a seal from an ampule and inserting the standard composition from the ampule into the chromatograph system. Thorson discloses the step of injecting includes removing a seal from an ampule and inserting the standard composition from the ampule into the chromatograph system (Figs. 1, 22-23, opening ampoule of preparative chromatography standard via UV and MS injected into column; ¶¶ [0209]-[0212]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing the step of injecting includes removing a seal from an ampule and inserting the standard composition from the ampule into the chromatograph system as in Thorson in order to provide greater efficiency in evaluating the condition of the chromatography system.
Regarding Claim 18, Jones discloses the method of claim 16, but is silent regarding the step of detecting includes using a detector chosen from an ultraviolet detector, a fluorescent detector, or an evaporative light scattering detector. Thorson discloses the step of detecting includes using a detector chosen from an ultraviolet detector, a fluorescent detector, or an evaporative light scattering detector (Figs. 1, 22-23, opening ampoule of preparative chromatography standard via UV and MS injected into column; ¶¶ [0209]-[0212]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing the step of detecting includes using a detector chosen from an ultraviolet detector, a fluorescent detector, or an evaporative light scattering detector as in Thorson in order to provide greater efficiency in evaluating the condition of the chromatography system.
Regarding Claim 19, Jones discloses the method of claim 16, but is silent regarding the chromatograph system has just been installed. Thorson discloses the chromatograph system has just been installed (¶¶ 0156]-[0158], [0163]-[0164]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing the chromatograph system has just been installed as in Thorson in order to provide greater efficiency in evaluating the condition of the chromatography system.
Regarding Claim 20, Jones discloses the method of claim 16, but is silent regarding comparing the elution rates against known elution rates to determine if a module of the chromatograph system is not working. Thorson discloses comparing the elution rates against known elution rates to determine if a module of the chromatograph system is not working (Fig. 1, result of the benchmark from comparison; ¶¶ [0028]-[0037]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing comparing the elution rates against known elution rates to determine if a module of the chromatograph system is not working as in Thorson in order to provide greater efficiency in evaluating the condition of the chromatography system.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jones in view of CN 106501398 to Zhou.
Regarding Claim 12, Jones discloses the composition of claim 1, and further discloses the composition comprises caffeine, benzophenone, di-ethyl phthalate, and di-octyl phthalate. (Figs. 1-2 and 5-6, NIST external standard sample having one or more added standards including caffeine, benzophenone, and Diethyl phthalate, Dimethyl phthalate, Dipentyl phthalate, Dibutyl phthalate, Dioctyl phthalate, etc; ¶¶ [0017]-[0020], [0064]-[0071], [0086]-[0087]). However, Jones is silent regarding the composition comprises di-amyl phthalate, di-n-hexyl phthalate. Zhou discloses the composition comprises di-ethyl phthalate, di-amyl phthalate, di-n- hexyl phthalate, and di-octyl phthalate (¶¶ [0053]-[0058]). It would have been obvious to one of ordinary skill in the art before the effective filing of the application to modify the invention of Jones by providing the composition comprises di-ethyl phthalate, di-amyl phthalate, di-n-hexyl phthalate, and di-octyl phthalate as in Zhou in order to provide greater accuracy for measuring with the chromatography system at least one of a desired peak width, peak area, retention time, and peak resolution.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed 11/10/2025, with respect to the rejection(s) of claim(s) 16-20 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 20110282587 to Jones.
Applicant’s arguments with respect to claim(s) 1-2, 5 and 9-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Furthermore, Applicant asserts that “Zahler does not disclose the limitations of claims 1, 2, 5, and 9-11 in such a way that a person of ordinary skill in the art could "at once envisage" the claimed invention.” The examiner disagrees. Although many species of soluble targets are listed, a person of ordinary skill in the art could "at once envisage” the many possible combinations thereof. Similarly, Jones discloses combinations of one or more standards and further discloses a database including reference sets of mass spectrometry data, which improves/simplifies the selection of standards to cover a broad range of properties to useful values within the dynamic range of the instrument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID J BOLDUC whose telephone number is (571)270-1602. The examiner can normally be reached M-F, 10am-6pm.
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/DAVID J BOLDUC/Primary Examiner, Art Unit 2852